EUS-FNA for Retropharyngeal Lymph Node (RPLN) in Recurrent Nasopharyngeal Carcinoma (NPC) Patients

NCT03006588 | Unknown Phase 2 DMC

• 1 other identifier: EUS-FNA for RPLN(2016)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

EUS-FNA for RPLN in NPC

Conditions

Nasopharyngeal Carcinoma

Keywords

FNA,EUS,retropharyngeal lymph node (RPLN),NPC

Outcome Measures

Primary Outcomes (1)

• Accuracy

  Number of participants with cancer positive and negative

  Up to 24 weeks

Study Arms (1)

EUS-FNA for RPLN in NPC patients

EXPERIMENTAL

Fine needle aspiration guided by EUS in retropharyngeal lymph node in suspicious recurrent naspharyngeal carcinoma.

Procedure: EUS-FNA for RPLN in NPC patients

Interventions

EUS-FNA for RPLN in NPC patients PROCEDURE

An EUS probe was introduced to nasopharynx and the retropharyngeal space (RPS) were scanned. The suspicious recurrent RPLN, which was characterized as (1) roughly round and homogeneously hypo-echoic lesion in RPS; (2) located anterior to the carotid sheath which contained the internal carotid artery (ICA) and the internal jugular vein (IJV). Subsequently, guiding by EUS, a dedicated 22G needle was used to puncture into the enlarged RPLN, then the aspiration was conducted The entire EUS-FNA procedure was repeated at least three times till the satisfied strip tissue was obtained. The obtained tissue samples were sent for pathologic detection and the supernatant fluid was for thinprep cytologic test (TCT).

EUS-FNA for RPLN in NPC patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• had undifferentiated, non-keratinizing carcinoma at the initial diagnosis (WHO, 1991 criteria) and no evidence of distant metastasis obtained before radiotherapy;
• received regular chemotherapy with cytotoxic agents such as cisplatin, carboplatin, 5-fluorouracil, paclitaxel, etc, and coordinated with radiotherapy with standard doses (approximate 50-70 Gy) in nasopharynx and neck respectively. Within 3 months after radiotherapy, no local and distant lesions were found;
• during regular follow-up , the enlarged RPLN was detected by MRI more than 6 months later since radiotherapy accomplished;
• didn't receive chemotherapy radiotherapy, immunotherapy or salvage surgery from completion of radiotherapy to suspicious recurrent lesion in RPLN detected;
• no recurrent lesion in nasopharynx was found by white light endoscopy as well as cancer cell negative in pathology by bite biopsy;
• single lesion in RPLN, and no other recurrent or metastatic lesion was found in local region or distant organ.
• the minimum axial diameter of RPLN was more than 5mm.

You may not qualify if:

• (1) patients with nasal stenosis; (2) patients with coagulation dysfunction; (3) patients with distant metastasis

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Jian-jun Li, MD & Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-jun Li, MD & Ph.D

CONTACT

+862087342822; lijj@sysucc.org.cn

Xin-xi Zhou, MD

CONTACT

+862087343135; zhouxx@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: December 30, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 2, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)